Postoperative DeliriumNCT05707741
Dexmetomedine for Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia
A study testing dexmetomedine infusion in people with Postoperative Delirium, run by Menoufia University at 1 site in Egypt.
Trial summary
Postoperative delirium is a geriatric syndrome occurring after anesthesia and surgery which manifests as acute alterations in mental status, involving changes in cognition, attention, and levels of consciousness that tend to fluctuate The use of dexmedetomidine with the intention to prevent postoperative delirium… Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- dexmetomedine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ASA physical status I- II
- Age from 65to 75 years old,
- Elective total knee arthroplasty under spinal anaesthesia.
Who cannot join
- Bleeding disorders
- Allergy to any of the drugs used in the study
- Renal insufficiency
- Liver failure-Neurological abnormalities -patients with hearing and visual impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Doses of Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Elective Total Knee Arthroplasty Under Spinal Anesthesia: A Pilot Randomized Controlled Trial
Postoperative delirium is a geriatric syndrome occurring after anesthesia and surgery which manifests as acute alterations in mental status, involving changes in cognition, attention, and levels of consciousness that tend to fluctuate The use of dexmedetomidine with the intention to prevent postoperative delirium remains controversial. Where it has shown to be effective in older adult patients undergoing cardiovascular and non-cardiovascular surgeries
Read the detailed description
On the day of surgery and after arrival to the theatre, all patients will have supplemental oxygen by nasal cannula at 5 L min-1 and will be connected to the standard monitoring non-invasive blood pressure, electrocardiography, and pulse oximetry. crystalloid 10mg/kg will be administered then all patients will receive spinal anaesthesia in the sitting position, under complete aseptic technique. The midline or Para median spinal puncture will be performed. volume of 3 ml of hyperbaric bupivacaine (Marcaine® Spinal Heavy 0.5%, AstraZeneca) will be injected using a 25 G spinal needle . After establishment of spinal anesthesia , A loading dose of dexmetomedine (1 µg/kg) will be administered for 10 min for all the patients then Three types of syringes will be prepared on 50 ml syringes Group A: saline 50 ml, Group B: a 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg, and Group C: a 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg. the patients then they will be randomized into 3 groups
- Conditions
- Postoperative Delirium
- Being tested
- dexmetomedine infusion, Placebo
- Keywords
- Delirium , Dexmetomedine
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmetomedine infusionDrug
50 ml mixture of saline 49 ml and dexmedetomidine 100 μg,
Dexmetomedine infusionDrug
50 ml mixture of saline 48 ml and dexmedetomidine 200 μg
PlaceboDrug
Normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | normal saline infusion Receives: Drug: Placebo |
| Group B | Active comparator | dexmetomedine 0.2 µg/kg/hr Receives: Drug: dexmetomedine infusion |
| Group C | Active comparator | dexmetomedine 0.4 µg/kg/hr Receives: Drug: dexmetomedine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive functions
Confusion Assessment Method (CAM)
Measured: 3 days
Secondary outcomes (2)
Post operative pain
VAS (0_10)
Measured: 3days
Sedation
Ramsay sedation score
Measured: 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Jun 2023
- Primary completion2 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
- Investigators
- rabab M habeeb, Dr, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707741
- Sponsor's protocol ID
- 1/2023,ANET2-2
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Elective Total Knee Arthroplasty Under Spinal Anesthesia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05707741
- Acronym / sponsor ID
- 1/2023,ANET2-2
- Conditions
- Postoperative Delirium
- Keywords
- Delirium , Dexmetomedine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative delirium is a geriatric syndrome occurring after anesthesia and surgery which manifests as acute alterations in mental status, involving changes in cognition, attention, and levels of consciousness that tend to fluctuate The use of dexmedetomidine with the intention to prevent postoperative delirium remains controversial. Where it has shown to be effective in older adult patients undergoing cardiovascular and non-cardiovascular surgeries
Detailed description
On the day of surgery and after arrival to the theatre, all patients will have supplemental oxygen by nasal cannula at 5 L min-1 and will be connected to the standard monitoring non-invasive blood pressure, electrocardiography, and pulse oximetry. crystalloid 10mg/kg will be administered then all patients will receive spinal anaesthesia in the sitting position, under complete aseptic technique. The midline or Para median spinal puncture will be performed. volume of 3 ml of hyperbaric bupivacaine (Marcaine® Spinal Heavy 0.5%, AstraZeneca) will be injected using a 25 G spinal needle . After establishment of spinal anesthesia , A loading dose of dexmetomedine (1 µg/kg) will be administered for 10 min for all the patients then Three types of syringes will be prepared on 50 ml syringes Group A: saline 50 ml, Group B: a 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg, and Group C: a 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg. the patients then they will be randomized into 3 groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: Placebonormal saline infusion |
| Group B | Active comparator | Drug: dexmetomedine infusiondexmetomedine 0.2 µg/kg/hr |
| Group C | Active comparator | Drug: dexmetomedine infusiondexmetomedine 0.4 µg/kg/hr |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ASA physical status I- II
- Age from 65to 75 years old,
- Elective total knee arthroplasty under spinal anaesthesia.
Key exclusion criteria (4 listed)
- Bleeding disorders
- Allergy to any of the drugs used in the study
- Renal insufficiency
- Liver failure-Neurological abnormalities -patients with hearing and visual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmetomedine infusion50 ml mixture of saline 49 ml and dexmedetomidine 100 μg, | Drug | Group B, Group C |
| Dexmetomedine infusion50 ml mixture of saline 48 ml and dexmedetomidine 200 μg | Drug | Group B, Group C |
| PlaceboNormal saline infusion | Drug | Group A |
Primary outcome
cognitive functions
Time frame: 3 days
Confusion Assessment Method (CAM)
2 secondary outcomes
Post operative pain
Time frame: 3days
Sedation
Time frame: 3days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rabab M habeeb, Dr principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmetomedine infusion in people with Postoperative Delirium, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive functions (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.